* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

20

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Age: 18 years and older.

Sex: Females not of child bearing potential and males.

No hormonal contraceptives or hormonal replacement therapies are permitted in this study.

Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels > 40 mIU/ml, or

bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or

total hysterectomy and an absence of bleeding for at least 3 months.

During the course of the study, from study screen until study exit - including the washout period, all men must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. These instructions should be documented in the informed consent form.

Weight Restrictions:

At least 60 kg (132 lbs) for men and

At least 48 kg (106 lbs) for women

All subjects will have a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19 (see Part II, Administrative Aspects of Bioequivalence Protocols). BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 18.5 rounds up to 19)

All subjects should be judged by the principal or sub-investigator physician listed on the Form FDA 1572 as normal and healthy during a pre-study medical evaluation performed within 21 days of the initial dose of study medication which will include:

Negative urine drug screen for all of the following compounds: amphetamines, barbiturates, benzodiazepines, cannabinoid, cocaine, methadone, opiates, and phencyclidine

Exclusion Criteria:

Institutionalized subjects will not be used.

Social Habits:

Use of any tobacco-containing products within 1 year of the start of the study.

Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.

Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.

Any recent, significant change in dietary or exercise habits.

Individual has a history of drug and/or alcohol abuse.

Medications:

Use of any prescription or over-the-counter (OTC) medications within fourteen (14) days prior to the initial dose of study medication.

Use of any hormone replacement therapy within 3 months prior to study medication dosing.

Use of any medication known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial dose of study medication (see Part II, Administrative Aspects of Bioequivalence Protocols for list).